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A First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
Sponsor: Bayer
Summary
The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors. For this, the researchers will study and analyze: * the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose. * the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses. * the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses. Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse. The study participants will take part in one of the seven distinct groups or "intervention cohorts" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase. Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems. Participants will visit the study site: * at least twice before the treatment starts * multiple times when they start taking the treatment * once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram * check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan * take tumor samples The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.
Official title: A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
370
Start Date
2025-03-21
Completion Date
2029-06-17
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
BAY 3713372
Daily oral administration
Locations (58)
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
City of Hope - Duarte Cancer Center
Duarte, California, United States
UCLA Health Bowyer Oncology Center
Los Angeles, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights - Neurology
San Francisco, California, United States
Stanford University Medical Center - Neurology
Stanford, California, United States
UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, United States
Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
Denver, Colorado, United States
Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
Orlando, Florida, United States
Massachusetts General Hospital - Neurology
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, United States
START | Midwest
Grand Rapids, Michigan, United States
Icahn School of Medicine at Mount Sinai - Oncology
New York, New York, United States
Memorial Sloan Kettering Cancer Center New York - Main Campus
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Dallas - Oncology Department
Irving, Texas, United States
START | San Antonio
San Antonio, Texas, United States
Froedtert Hospital - Clinical Cancer Center
Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre
Concord, New South Wales, Australia
Northern Hospital
Epping, New South Wales, Australia
Calvary Mater Hospital Newcastle - Oncology
Waratah, New South Wales, Australia
UZ Leuven Gasthuisberg - Pneumology Department
Leuven, Vlaams-Brabant, Belgium
Antwerp University Hospital | Oncology Department
Antwerp, Belgium
Ghent University Hospital | Drug Research Unit Department
Ghent, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology
Liège, Belgium
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, China
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
Brno, Czechia
Fakultní nemocnice Olomouc - Onkologická klinika
Olomouc, Czechia
Rigshospitalet - Kræftbehandling
Copenhagen, Capital Region, Denmark
Odense University Hospital - Oncology Department
Odense, Region Syddanmark, Denmark
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
Aviano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
Roma, Italy
I.F.O. Istituti Fisioterapici Ospitalieri - Sperimentazioni cliniche Fase 1 e Medicina di precisione
Roma, Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shizuoka Cancer Center
Sunto, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Nederlands Kanker Instituut
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center
Groningen, Netherlands
National University Hospital Medical Centre
Singapore, Singapore
National Cancer Center Singapore - Oncology Department
Singapore, Singapore
Icon Cancer Centre
Singapore, Singapore
Hospital San Pedro | Oncologia
Logroño, La Rioja, Spain
Clinica Universidad De Navarra | Pamplona | Oncologia
Pamplona, Madrid, Spain
NEXT - Hospital Universitario Quironsalud Madrid | Oncologia
Pozuelo de Alarcón, Madrid, Spain
Hospital Hm Nou Delfos | Oncologia
Barcelona, Spain
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia
Madrid, Spain
Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, Spain
Hospital Clinico Universitario De Valencia | Oncologia
Valencia, Spain
Karolinska Universitetssjukhuset - Fas I-enheten Solna CKC
Stockholm, Stockholm County, Sweden
Sahlgrenska Universitetssjukhuset - Klinisk prövningsenhet Fas I/FIH
Gothenburg, Västra Götaland County, Sweden
The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
Sutton, Surrey, United Kingdom
The Christie NHS Foundation Trust | Christie Hospital - Experimental Cancer Medicine Team
Manchester, United Kingdom